The policy update expands commercial coverage to approximately 90 million eligible individuals across the US.
Carelon Healthcare Services has updated its clinical guidelines to cover Guardant Health’s Shield blood test for colorectal cancer (CRC) screening, effective Nov 15.
The policy update increases total covered lives for the Shield test to approximately 90 million, representing roughly 75% of eligible patients in the US, according to the company. Carelon Healthcare Services provides specialty benefits management to Blue Cross Blue Shield plans across 26 states, including California, New York, Texas, and Illinois.
“With the largest major medical benefit manager in the U.S. to cover the Shield blood test for their members, approximately 90 million people nationwide now have access to Shield, bringing the most clinically-validated blood-based colorectal cancer screening option within reach for the vast majority of the eligible US population,” says AmirAli Talasaz, Guardant Health co-CEO, in a release. “As we see colorectal cancer rates continue to rise for those under 65, including younger adults, access to Shield through Carelon marks another critical milestone in our commercial expansion and broader mission to make screening more accessible.”
Screening Technology and Clinical Evidence
Shield is a methylation partitioning cell-free DNA blood-based screening test designed to detect alterations associated with colorectal cancer from a standard blood draw during routine clinical visits. The assay is approved by the Food and Drug Administration for primary CRC screening in average-risk adults aged 45 and older.
According to Guardant Health, the test is not intended for individuals at high risk for CRC. A positive test result indicates potential presence of colorectal cancer or advanced adenoma, requiring follow-up evaluation by colonoscopy.
The test is recommended in clinical guidelines from the American Cancer Society and the National Comprehensive Cancer Network. According to company data, more than 200,000 Shield tests have been performed in real-world settings, demonstrating an adherence rate of over 90% among patients due for CRC screening across various healthcare systems and clinical practices.
